Devices & Diagnostics

FDA, Minnesota device industry to collaborate on regulatory science

How can there be speedy, early assessments of new innovative medical devices? The U.S. Food and Drug Administration and the Minnesota medical device community may have hit upon an answer. At the close of a two-day visit to Minnesota Tuesday by Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, and […]

How can there be speedy, early assessments of new innovative medical devices?

The U.S. Food and Drug Administration and the Minnesota medical device community may have hit upon an answer.

At the close of a two-day visit to Minnesota Tuesday by Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, and some CDRH staff, a Minnesota trade group announced that a new public-private partnership will be formed focusing on regulatory science.

Regulatory science is a set of tools and methods for evaluating the safety, effectiveness, quality and performance of medical devices.

“As a country we don’t invest in regulatory science as opposed to basic science or translational science,” Shuren said.

Details of the partnership, which is still in nascent stage, were not available. But Dale Wahlstrom, president and CEO of LifeScience Alley, the trade group that facilitated Shuren’s trip to Minnesota, said that creating its structure is the group’s No. 1 priority. The hope is that if the tools for regulatory science are identified and new devices developed using those tools, the path to regulatory clearance will be smoother. If the pilot works in Minnesota, it can also serve as a national model for medical devices safety and clearance.

Shuren told the audience gathered in St. Paul that such a broad public-private partnership involving the FDA is a first for the medical devices industry. However, such collaborative models do exist with drug makers. Shuren’s deputy echoed his comments.

“Regulatory science has helped lay the foundation for new drug development,” said Dr. William Maisel, deputy director for science.

One such regulatory science tool is computer modeling, Shuren said. That can take the place of very expensive testing. Further, having such a partnership may help to clarify what tools are required to assess new technology like nanotech, Wahlstrom added.

Wahlstrom explained that the public-private partnership, whatever form it takes, is meant to engage small, medium and large medical device companies, although they will have have different levels of involvement depending on their needs.

“It is meant to advance the entire industry,” he said.

Maisel also hastened to remove any notion that the FDA will be the 800-pound gorilla in the collaboration and sought to manage expectations.

“It’s not a partnership with FDA steering the ship,” he said. “Building science takes time. This is not going to be an immediate solution to problems of industry.”